Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2085402

FEI Number

1000519735

Entity Name

BIOSYS LABORATORIES, INC.

City/State/Country

S Pasadena, CA, US

Establishment Address

526 Mission Street, S Pasadena, CA 91030, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

BIOSYS LABORATORIES, INC. (Owner Number: 9012318)

Owner / Operator Contact Address

526 Mission Street, South Pasadena, CA 91030, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2025-11-19

Official Correspondent

JESSICA KAO

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIOSYS LABORATORIES, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2085402. Last updated year: 2026. Please use registration number 2085402 when referencing this establishment in official correspondence.